Associate System Analyst

What you will do

In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features.

Roles & Responsibilities:

• Develop comprehensive test plans and strategies based on project specifications and requirements.
• Perform manual and automated testing of software applications, including functional, regression, and performance testing.
• Document and report defects identified during testing and collaborate with development teams for resolution.
• Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance.
• Validate test scenarios against feature acceptance criteria and customer expectations.
• Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability.
• Find opportunities to enhance testing efficiency and minimize manual efforts.
• Evaluate and adopt tools and technologies to improve automation capabilities.
• Keep validation documentation updated and aligned with GxP standards.
• Ensure strict consistency to change management processes for validated systems.
• Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP, DevOps and Test Automation.
• Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, fix, and improving new and existing applications and platforms.
• Collaborate with business and data collaborators to gather requirements, assess data needs, and ensure data quality, privacy, and compliance across ETL pipelines.
• Maintain detailed documentation of software designs, code, and development processes.
• Work on integrating with other systems and platforms to ensure seamless data flow and functionality.
• Stay up to date on Veeva Vault Features, new releases and standard processes around Veeva Platform Governance.

What we expect of you

Basic Qualifications and Experience:

• Bachelors degree and 2 to 6 years of Information Systems experience or related field.

Functional Skills:

Must-Have Skills:

• Experienced in GxP validation process in Pharmaceutical Industry
• Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
• Experience with HP ALM/Veeva Validation Manager (VVM)
• Experience with Agile software development methodologies (Scrum)
• Superb communication skills and the ability to work with senior leadership with confidence and clarity
• Experience in writing requirements for the development of a modern web application
• Solid understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11
• Proficiency in automation tools, data systems, and validation software

Good-to-Have Skills:

• Experience with Veeva Vault and its applications, including Veeva configuration settings and custom builds
• Outstanding written and verbal communication skills, and ability to translate technical concepts for non-technical audiences
• Familiarity with low-code, no-code test automation software
• Able to communicate technical or complex subject matters in business terms
• Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology

Professional Certifications:

• Veeva Vault Platform Administrator or Equivalent Vault Certification (Preferred)
• SAFe for Teams (Preferred)

Soft Skills:

• Excellent analytical and fix skills.
• Strong verbal and written communication skills.
• Ability to work effectively with global, virtual teams.
• Team-oriented, with a focus on achieving team goals.
• Strong presentation and public speaking skills.

Work Hours: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required. Potential Shifts (subject to change based on business requirements): Second Shift: 2:00pm 10:00pm IST; Third Shift: 10:00 pm 7:00 am IST.